LifeVac, Dechoker, and Abdominal Thrusts for Choking

Overseen By Cody Dunne, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Physical disability, Healthcare training

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of different methods for assisting someone who is choking. It compares traditional techniques, such as abdominal thrusts, with newer devices like LifeVac and Dechoker to determine which clears an airway most effectively. Participants will watch a video and then practice these methods on a mannequin to simulate a real-life choking scenario. Adults without healthcare training who can perform these actions may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to potentially life-saving research and enhance emergency response techniques.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these airway clearance techniques are safe for use by laypersons?

Studies have shown some safety concerns with both LifeVac and Dechoker. Research indicates that these devices can create strong suction on the tongue and throat, potentially causing swelling. These devices are not FDA-approved, although they are registered with the FDA, meaning they haven't undergone the same thorough safety checks as some other medical devices.

While both devices have been used successfully in various situations, the safety findings suggest caution. Prospective trial participants should consider these points carefully. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different methods to address choking, a critical emergency situation. Unlike the traditional method of abdominal thrusts (also known as the Heimlich maneuver), this study includes devices like the Dechoker and LifeVac, which offer non-invasive alternatives. These devices work by creating suction to remove obstructions from the airway, potentially providing a safer option for individuals who cannot receive abdominal thrusts due to medical conditions or age. The trial aims to determine the most effective sequence of these interventions, which could lead to better outcomes and save lives in choking emergencies.

What evidence suggests that this trial's treatments could be effective for choking?

This trial will compare the effectiveness of LifeVac, Dechoker, and abdominal thrusts in various sequences for choking emergencies. Research has shown that both LifeVac and Dechoker can be helpful in such situations. Specifically, the LifeVac device has proven very effective, successfully clearing blocked airways in up to 99% of cases and working faster than other methods. The Dechoker also clears obstructions in about 74% of cases, though some reports mention minor injuries, such as tongue damage. Traditional abdominal thrusts work in about 71% of cases. Overall, LifeVac appears to provide the most reliable results among the options tested. Participants in this trial will experience different sequences of these methods to determine the most effective order. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This study is for adults aged 18 or older who can communicate in English. It's designed to evaluate how well people can use different choking relief techniques, such as LifeVac, Dechoker, and abdominal thrusts on a simulation mannequin after watching an instructional video.

Inclusion Criteria

I can communicate in English to sign informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-simulation Orientation

Participants receive an orientation to the simulator and environment, and are briefed on the outcomes being assessed.

1 day

1 visit (in-person)

Intervention

Participants view educational videos and perform choking interventions on a simulation mannequin using LifeVac, Dechoker, and Abdominal Thrusts.

1 day

1 visit (in-person)

Follow-up

Participants are invited back to repeat the scenarios to assess skills retention.

90-120 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Abdominal Thrusts
• Dechoker
• LifeVac

Trial Overview

The trial tests three interventions for relieving airway obstruction: LifeVac, Dechoker, and traditional abdominal thrusts. Participants will watch a video demonstration of each technique before attempting to clear a blockage on a mannequin. They'll be retested after 90-120 days to see if they remember the techniques.

How Is the Trial Designed?

Group I: LV - DC - AT Experimental Treatment 3 Interventions

Order: LifeVac then Dechoker then Abdominal Thrusts

Group II: LV - AT - DC Experimental Treatment 3 Interventions

Order: LifeVac then Abdominal Thrusts then Dechoker

Group III: DC - LV - AT Experimental Treatment 3 Interventions

Order: Dechoker then LifeVac then Abdominal Thrusts

Group IV: DC - AT - LV Experimental Treatment 3 Interventions

Order: Dechoker then Abdominal Thrusts then LifeVac

Group V: AT - LV - DC Experimental Treatment 3 Interventions

Order: Abdominal Thrusts then LifeVac then Dechoker

Group VI: AT - DC - LV Experimental Treatment 3 Interventions

Order: Abdominal Thrusts then Dechoker then LifeVac

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Canadian Association of Emergency Physicians

Industry Sponsor

Trials

9

Recruited

1,000+

Published Research Related to This Trial

A new method for synthesizing organophosphorus compounds from common aryl and vinyl carboxylic acids using decarbonylative palladium catalysis has been developed, demonstrating excellent versatility with over 50 functional groups.

The study includes DFT analyses that reveal the reasons behind the high selectivity in bond activation and the isomerization pathway of P(O)-H, enhancing our understanding of the reaction mechanism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decarbonylative Phosphorylation of Carboxylic Acids via Redox-Neutral Palladium Catalysis. Liu, C., Ji, CL., Zhou, T., et al.[2022]

The study presents a new method for synthesizing disubstituted alkyne compounds using a copper-catalyzed decarboxylative coupling process, which is effective at just 2 mol% copper loading.

This method is highlighted as simple, economical, and practical, making it a valuable approach for organic synthesis in the laboratory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Highly effective copper-catalyzed decarboxylative coupling of aryl halides with alkynyl carboxylic acids. Qu, X., Li, T., Sun, P., et al.[2013]

A new Pd-catalyzed method allows for the efficient construction of nine-membered carbocycles using vinyl methylene cyclic carbonates and allylidenemalononitriles, with CO2 as the only byproduct.

This strategy offers controllable regioselectivity and also explores the formation of valuable seven-membered carbocycles, highlighting its versatility in synthetic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinetically Controllable Construction of Nine-Membered Carbocycles via Pd-Catalyzed Decarboxylative Cycloaddition. Liu, Y., He, Y., Liu, Y., et al.[2022]

In a study using a fresh cadaver model, the DeChoker device caused significant injury to the tongue and failed to remove any foreign body, while the LifeVac only successfully removed saltine crackers but not other aspirated items.

Both devices applied considerable pressure to the oral cavity, raising concerns about potential injury, and the study suggests that bystanders should adhere to established resuscitation guidelines rather than relying on these devices for foreign body aspiration emergencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of two commercially available devices for airway foreign body relief: A cadaver study. Ramaswamy, A., Done, A., Solis, R., et al.[2023]

A new one-pot chemical reaction allows for the efficient creation of 2,4-diolefinic and 2,4,6-triolefinic monocarboxylic acids from aldehydes and glutaconic acid, which can be used as building blocks in organic chemistry.

This method is versatile, applicable to both saturated and unsaturated aldehydes, providing a straightforward approach to produce valuable organic compounds and reactive intermediates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-pot formation of 2,4-di- or 2,4,6-tri-olefinic monocarboxylic acids by straight chain C4-extension. Sobotta, J., Schmalhofer, M., Steiner, TM., et al.[2022]

Airway clearance devices (ACDs) like LifeVac and Dechoker have shown promise in resolving choking symptoms, with successful outcomes reported in 123 cases for LifeVac and 60 cases for Dechoker among a total of 185 interventions.

The use of ACDs resulted in a low incidence of adverse events (1.6%), indicating they are generally safe, but further independent studies are needed to enhance data quality and refine choking intervention protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase One of a Global Evaluation of Suction-Based Airway Clearance Devices in Foreign Body Airway Obstructions: A Retrospective Descriptive Analysis. Dunne, CL., Osman, S., Viguers, K., et al.[2023]

In a study involving 27 choking incidents in UK adult care homes, the DeChoker Airway Clearance Device successfully removed obstructions in 26 cases, demonstrating high efficacy with minimal complications.

Care home staff reported that the DeChoker was easy to use and effective, with 78% of victims not needing to visit Accident and Emergency, suggesting it could be a valuable tool in managing choking emergencies, especially for individuals with limited mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of DeChoker, an Airway Clearance Device (ACD) Used in Adult Choking Emergencies Within the Adult Care Home Sector: A Mixed Methods Case Study. Bhanderi, BG., Palmer Hill, S.[2023]

The LifeVac, a novel portable non-powered suction device, has been reported to successfully resuscitate 38 out of 39 adults with oropharyngeal dysphagia during choking emergencies over a 6-year period, indicating its potential efficacy in real-world situations.

The device presents a minimal risk and may serve as a valuable alternative for resuscitating choking patients when traditional methods like abdominal thrusts or back blows are ineffective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Novel Portable Non-powered Suction Device in Patients With Oropharyngeal Dysphagia During a Choking Emergency. McKinley, MJ., Deede, J., Markowitz, B.[2022]

The Heimlich manoeuvre is effective for managing choking, and this study found that the method of performing abdominal thrusts (upthrust vs circumferential) does not change the pressure generated in the chest, which is crucial for dislodging an obstruction.

Self-administered abdominal thrusts can generate similar pressures as those performed by another person, and using a chair for thrusts can produce even higher pressures, suggesting that both methods should be included in basic life support training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choking on a foreign body: a physiological study of the effectiveness of abdominal thrust manoeuvres to increase thoracic pressure. Pavitt, MJ., Swanton, LL., Hind, M., et al.[2022]

Untrained health science students were able to effectively use the LifeVac® and DeCHOKER® anti-choking devices in simulated choking scenarios, achieving compliance rates between 80-100%.

The LifeVac® device was significantly faster to use than the DeCHOKER®, with an average completion time of 36.6 seconds compared to 50.4 seconds, suggesting it may be more efficient in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Would anti-choking devices be correctly and quickly managed by health science students? A manikin crossover trial. Cardalda-Serantes, B., Carballo-Fazanes, A., Rodríguez-Ruiz, E., et al.[2023]

A new method using a copper catalyst allows for the efficient cross-coupling of α-amino acids with various C-H nucleophiles to create different types of carbon bonds without needing additional ligands or oxidants.

This technique not only produces nitrogen-containing compounds in good to excellent yields but also demonstrates practicality through successful gram-scale experiments and the synthesis of a Rad51 inhibitor in just three steps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Copper-catalyzed aerobic decarboxylative coupling between cyclic α-amino acids and diverse C-H nucleophiles with low catalyst loading. Guo, J., Xie, Y., Wu, QL., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10278115/

The efficacy of two commercially available devices for ...

Results. The DeChoker resulted in gross injury to the tongue and failed to remove the obstruction in all trials. LifeVac was successful in removing the barium‐ ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7793855/

Evaluation of DeChoker, an Airway Clearance Device ...

The device was reported to have successfully removed the obstruction in 26 of 27 cases, with very few complications or adverse events reported. In 21 of 27 ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1755599X25000059

A systematic review on suction-based airway clearance ...

The Dechoker® device successfully resolved airway obstruction in 33 out of 35 cases, leading to the restoration of normal breathing. Preliminary evidence ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666520420300680

The efficacy and usability of suction-based airway ...

For the primary outcome, the FBAO was successfully removed in 99% cases with LifeVac, 74% cases with Dechoker, and 71% cases with abdominal thrusts (Table 2).

5.

resuscitationjournal.com

resuscitationjournal.com/article/S0300-9572(22)00567-6/fulltext

Anti-choking suction devices use. A pilot simulated study ...

They showed a higher number of successful FBAO removal in a shorter time with LifeVac® (82% in the first minute compared to 44% cases using ...

6.

fda.gov

fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dechoker-llc-614629-05102021

DeChoker LLC MARCS-CMS 614629 — May 10, 2021

This inspection revealed that the Dechoker device is adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that ...

7.

gov.uk

gov.uk/government/news/mhra-warns-of-unsafe-counterfeit-anti-choking-devices

MHRA warns of unsafe counterfeit anti-choking devices

There are currently two anti-choking device brands, LifeVac and Dechoker, which have a valid UKCA or CE mark and are registered with the MHRA ...

8.

goodrx.com

goodrx.com/health-topic/childrens-health/anti-choking-device-work?srsltid=AfmBOooLUuf2Rn9uuYmFig7tpYGP8ccCt87bnpzQFId7dZW0IUpZrCgi

Do Anti-Choking Devices Work? Experts Review

Are LifeVac and Dechoker FDA-approved? No, LifeVac and Dechoker are registered with the FDA, but they're not FDA-approved like medications are. ...